QA Release

Swiftwater, PA

Full time

R2874395

** Job Title** : QA Release

*
* Location:

** Swiftwater, PA

** About the job:*
* Your job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.

This role provides quality oversight of the batch release process.  This role will perform final batch release and lot disposition for product distributed from the Sanofi Swiftwater Site and release from relevant Commercial Manufacturing Organizations (CMOs)

** Benefits of working in this role:*
* + Be part of an inspiring mission to create life-saving vaccines

+ Leading a skilled and motivated team of quality professionals

+ The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and  Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

** About Sanofi:*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

** Main Responsibilities*
* + Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

+ Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

+ Reviewing batch records and associated documentation

+ Fostering a culture of quality and continuous improvement across the organization

+ Participating in internal and external audits and regulatory inspections providing support and documentation

+ Conducting risk assessments and implementing mitigation strategies for batch release processes

+ Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities

+ Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)

+ Collaborating with regulatory affairs to ensure compliance with local and international regulations

+ Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness

+ Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots

+ Perform and lead Environmental Data Summary Review, Lot Release Protocol generation/approval, and CMO release as applicable.

+ Any other tasks as assigned by team Lead

** Disposition of Batches*
* + Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.

+ Verify CBER release is received (if applicable) prior to batch disposition.

+ Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.

+ Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.

+ Complete all required system transactions associated with the batch disposition process.

+ Act as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned

** Key Involvement in Decision Making:*
* + Prioritize quality and compliance objectives (D)

+ Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

+ Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

+ Review and approve documentation for batch disposition (A)

+ Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages

+ Advise on initiatives to promote a quality-focused culture (A)

+ Advise on how to present a topic and answer specific questions (A)

** About You*
* ** Basic Qualifications*
* + Bachelor's degree.

+ 3+ years of experience in Quality Assurance within the pharmaceutical industry.

+ Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

**…